medical Class I Updated 2025-04-16

MEDLINE INDUSTRIES, LP - Northfield recalls Medline medical procedure kits, containing Medtronic Aortic

Recalled Product

Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CPB ADJUNCT PACK, DR. C PACK, PK CUST CV A&B C CO, TOL DR R PACK, TOL DR. C PACK, TOL DR. M PACK.

Hazard / Issue

Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.

Issued by

FDA

Affected States: CA, FL, MN, NY, OH, OR, PA, TX, WV
Lot/Code Info: TOL DR R PACK, UDI/DI 10198459054242 (ea) 40198459054243 (case), Lot Number 24IBV027; TOL DR. C PACK, UDI/DI 10195327176914 (ea) 40195327176915 (case), Lot Number 22HBX339; TOL DR. CRESCENZO PACK, UDI/DI 10195327273750 (ea) 40195327273751 (case), Lot Numbers 22LBC389, 23EBQ439, 23HBG138; TOL DR. C PACK, UDI/DI 10195327513818 (ea) 40195327513819 (case), Lot Numbers 23KBS878, 24CBB191, 24EBD828; TOL DR. C PACK, UDI/DI 10198459054259 (ea) 40198459054250 (case), Lot Numbers 24FBO426, 24HBP282, 24JBL545, 24LBR173; TOL DR. M PACK, UDI/DI 10195327513825 (ea) 40195327513826 (case), Lot Numbers 23KBC932, 24CBP602, 24EBV519; TOL DR. M PACK, UDI/DI 10198459054266 (ea) 40198459054267 (case), Lot Numbers 24GBI558, 24GBX898, 24IBE173, 24IBE173A, 25ABG352.
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